Poor literacy and health literacy levels are barriers to proper health care across all clinical areas. This includes the informed consent process within clinical research, which is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial.
According to the National Assessment of Adult Literacy, approximately 43% of American adults 16 years or older have ‘basic’ or ‘below basic’ literacy levels. It has been widely researched and acknowledged that the national average literacy level is well below that required to comprehend a typical IRB-approved informed consent. According to a recent study conducted at Duke University and UCLA, a typical ICF is at an approximately 11th grade reading level.
- The ICH E6 guideline states that:
“The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.”
- In the United States, 21 CFR Part 50.20 states that:
“The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”
Clearly there is a gap between the readability of ICFs and reading abilities of many potential trial participants, which stands in the way of subjects’ understanding, enrollment, and follow-up throughout a study. ICFs are often too complex, especially when the study involves novel technologies or experimental treatments.
Many IRBs, research institutions, and related organizations now offer tools and support, most for free online, for creating ICFs that are readable to the general population. Sponsors strive to tailor their ICF templates for each study to include all required components and explain the risks and benefits in a straightforward way. Even at the site-compliance level, monitors often review approved ICFs for any omissions in required content.
In 2010, the Plain Writing Act was signed into effect by President Obama, requiring US federal agencies to use ‘plain language’ and to train employees in the use of ‘plain language.’ As a result, a multitude of additional tools and free training courses are provided online that can be used for making ICFs more readable.
- Group Health Research Institute
- Free online course: Program for Readability in Science and Medicine (PRISM) training
- PRISM Readability tool kit, including how to determine the reading level of your document and many examples of plain language specifically useful in ICF development (pdf)
- Agency for Healthcare Research and Quality (AHRQ)
- Informed Consent and Authorization Toolkit for Minimal Risk Research
- Templates: University of South Florida, Johns Hopkins University, Agency for Healthcare Research and Quality ( AHRQ)
- Guidelines: University of Illinois Chicago, AAMC
The problem is widely acknowledged, and now tools are readily available. At all levels of clinical research, it is our responsibility to protect and educate patients so that they can give truly informed consent.
What are your experiences with complex informed consents, or with improving their readability? Share with us in the comments section!
Photo Credit: Ava Weintraub Photography